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minocycline hydrochloride
Overview
What is Minocin?
MINOCIN minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.
Its structural formula is:
CHNO•HCl M.W. 493.94
MINOCIN Pellet-Filled Capsules for oral administration contain pellets of minocycline HCl equivalent to 50 mg, 75 mg or 100 mg of minocycline in microcrystalline cellulose.
The capsule shells contain the following inactive ingredients: Blue 1, Gelatin, Titanium Dioxide and Yellow 10. The 50 mg and 75 mg capsule shells also contain Black and Yellow Iron Oxides.
What does Minocin look like?
What are the available doses of Minocin?
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What should I talk to my health care provider before I take Minocin?
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How should I use Minocin?
MINOCIN Pellet-Filled Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.Respiratory tract infections caused by .Lymphogranuloma venereum caused by .Psittacosis (Ornithosis) due to .Trachoma caused by , although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by .Nongonococcal urethritis, endocervical, or rectal infections in adults caused by or .Relapsing fever due to .Chancroid caused by .Plague due to .Tularemia due to .Cholera caused by .Campylobacter fetus infections caused by .Brucellosis due to species (in conjunction with streptomycin).Bartonellosis due to .Granuloma inguinale caused by .
Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
Escherichia coli.
Enterobacter aerogenes.
Shigella
Acinetobacter
Haemophilus influenzae.
Klebsiella
MINOCIN Pellet-Filled Capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
Upper respiratory tract infections caused by
Skin and skin structure infections caused by (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
Uncomplicated urethritis in men due to and for the treatment of other gonococcal infections.Infections in women caused by .Syphilis caused by subspecies .Yaws caused by subspecies .Listeriosis due to .Anthrax due to .Vincent's infection caused by .Actinomycosis caused by .Infections caused by species.
In , minocycline may be a useful adjunct to amebicides.
In severe , minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.
Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by .
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules and other antibacterial drugs, MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
MINOCIN Pellet-Filled Capsules may be taken with or without food (See .)
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pellet-filled capsules should be swallowed whole.
For Pediatric Patients Above 8 Years Of Age
Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
Adults
The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.
In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.
For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.
Mycobacterium marinum
Uncomplicated urethral, endocervical, or rectal infection in adults caused by or : 100 mg orally, every 12 hours for at least 7 days.
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.
The pharmacokinetics of minocycline in patients with renal impairment (CL <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored. (See .)
What interacts with Minocin?
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What are the warnings of Minocin?
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What are the precautions of Minocin?
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What are the side effects of Minocin?
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What should I look out for while using Minocin?
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.
Tooth Development
Minocin, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
Skeletal Development
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Use in Pregnancy
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
Dermatologic Reaction
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately.
Antianabolic Action
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. (See .) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.
Photosensitivity
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.
Central Nervous System
Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
Clostridium difficile
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Intracranial Hypertension
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Minocin. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and Minocin should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
What might happen if I take too much Minocin?
The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting.
No specific antidote for minocycline is known.
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
How should I store and handle Minocin?
MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:NDC 16781-403-60 Bottle of 6075 mg, two-piece, hard-shell capsule with a white opaque cap and a yellow body, printed in black ink with "Onset" over "M075" on one half and "Onset" over “75 mg” on the other half. Each capsule contains pellets of minocycline HCl equivalent to 75 mg of minocycline, supplied as follows:NDC 16781-457-60 Bottle of 6050 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:NDC 16781-400-60 Bottle of 60Store at controlled room temperature 20° to 25°C (68° to 77°F).Protect from light, moisture, and excessive heat.Dispense in a tight, light-resistant container as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following a single dose of two MINOCIN 100 mg pellet-filled capsules administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 μg/mL (average 3.5 μg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).
When MINOCIN Pellet-Filled Capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of MINOCIN Pellet-Filled Capsules was unchanged compared to dosing under fasting conditions. The mean T was delayed by one hour when administered with food, compared to dosing under fasting conditions. MINOCIN Pellet-Filled Capsules may be administered with or without food.
In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines.
Non-Clinical Toxicology
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.Tooth Development
Minocin, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
Skeletal Development
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Use in Pregnancy
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
Dermatologic Reaction
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately.
Antianabolic Action
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours. (See .) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.
Photosensitivity
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline.
Central Nervous System
Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
Clostridium difficile
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Intracranial Hypertension
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including Minocin. Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH. Concomitant use of isotretinoin and Minocin should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
CNS Depressants -
Epinephrine -
Anticholinergics -
Monoamine Oxidase Inhibitors (MAOI) -
Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.
Body as a whole
Gastrointestinal
Genitourinary
Hepatic toxicity
Skin
Respiratory
Renal toxicity
Musculoskeletal
Hypersensitivity reactions
Blood
Central Nervous System
Other
Tooth discoloration in children less than 8 years of age (see ) and also, in adults has been reported.
Oral cavity discoloration (including tongue, lip, and gum) have been reported.
Tinnitus and decreased hearing have been reported in patients on MINOCIN.
The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately:
Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present.
Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis.
Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling. Eosinophilia may be present.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).